Skip to Content

← See all Childrens Loratadine brands

Childrens Loratadine by Preferred Pharmaceuticals Inc.

Medically reviewed on October 12, 2017

Dosage form: solution
Ingredients: Loratadine 5mg in 5mL
Labeler: Preferred Pharmaceuticals Inc.
NDC Code: 68788-7027

Children's Loratadine

Drug Facts

Active ingredient (in each 5 mL teaspoonful)

Loratadine 5 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

runny nose
itchy, watery eyes
sneezing
itching of the nose or throat

Warnings

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

When using this product do not take more than directed. Taking more than directed may cause drowsiness.

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions
use only with enclosed dosing cup

adults and children 6 years and over

2 teaspoonfuls (tsp) daily; do not take more than 2 teaspoonfuls (tsp) in 24 hours

children 2 to under 6 years of age

1 teaspoonful (tsp) daily; do not take more than 1 teaspoonful (tsp) in 24 hours

children under 2 years of age

ask a doctor

consumers with liver or kidney disease

ask a doctor

Other information
do not use if bottle wrap imprinted with "SEALED FOR SAFETY" is broken or missing.
see bottom panel for lot number and expiration date
store between 20° and 25°C (68° and 77°F)

Inactive ingredients

glycerin, grape flavor, maltitol solution, masking agent, noncrystallizing sorbitol solution, phosphoric acid, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sodium phosphate monobasic dihydrate, sucralose powder.

Questions?

Call 1-866-923-4914

Distributed by:
Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532

Relabeled By: Preferred Pharmaceuticals Inc.

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

NDC 68788-7027-1

Compare to the
active ingredient
in Children's Claritin®*

Original
Prescription
Strength

Children's
Loratadine
Oral Solution
USP, 5 mg/5 mL

(Antihistamine)
ALLERGY
Non-Drowsy

24 Hour
Relief of:

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

Indoor & Outdoor Allergies
Ages 2 years and older

WARNING: Contains sodium metabisulfite,
a sulfite that may cause allergic-type reactions.

Dye Free
Sugar Free
Grape
Flavor

Dosage Cup
Enclosed

When taken as directed.
See Drug Facts Panel.

4 FL OZ
(120 mL)

CHILDRENS LORATADINE 
loratadine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-7027(NDC:51672-2092)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Loratadine (Loratadine) Loratadine5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
glycerin 
sorbitol 
phosphoric acid 
POLYETHYLENE GLYCOL, UNSPECIFIED 
propylene glycol 
water 
sodium benzoate 
sodium metabisulfite 
sodium phosphate, monobasic, dihydrate 
Product Characteristics
ColorYELLOW (colorless to slightly yellow) Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:68788-7027-11 BOTTLE in 1 CARTON
1120 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07680510/12/2017
Labeler - Preferred Pharmaceuticals Inc. (791119022)
Registrant - Preferred Pharmaceuticals Inc. (791119022)
Establishment
NameAddressID/FEIOperations
Preferred Pharmaceuticals Inc.791119022RELABEL(68788-7027)

 
Preferred Pharmaceuticals Inc.

← See all Childrens Loratadine brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide